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The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study (ImPrOVE)

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ClinicalTrials.gov Identifier: NCT01102140
Recruitment Status : Terminated (Investigator left University of Michigan)
First Posted : April 13, 2010
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
Jennifer Cowger , MD, MS, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Cardiomyopathy
Heart Failure
Interventions Drug: POMx, pomegranate polyphenol extract
Drug: Sugar Pill
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title POMx Control- Sugar Pill
Hide Arm/Group Description

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

Period Title: Overall Study
Started 13 7
Completed 10 5
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             1             0
Investigator terminated study             2             2
Arm/Group Title POMx Control- Sugar Pill Total
Hide Arm/Group Description

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

Total of all reporting groups
Overall Number of Baseline Participants 13 7 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  76.9%
5
  71.4%
15
  75.0%
>=65 years
3
  23.1%
2
  28.6%
5
  25.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 13 participants 7 participants 20 participants
57
(49 to 64)
58
(52 to 64)
57
(50 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
Female
0
   0.0%
2
  28.6%
2
  10.0%
Male
13
 100.0%
5
  71.4%
18
  90.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 7 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
0
   0.0%
1
   5.0%
White
12
  92.3%
6
  85.7%
18
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  14.3%
1
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 7 participants 20 participants
13 7 20
1.Primary Outcome
Title Thiobarbituric Reactive Substances (TBARS)
Hide Description This is a serum marker of oxidative stress.
Time Frame baseline and after 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis.
Arm/Group Title POMx Control- Sugar Pill
Hide Arm/Group Description:

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title F-8 Isoprostanes
Hide Description This is a serum marker of oxidative stress.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis
Arm/Group Title POMx Control- Sugar Pill
Hide Arm/Group Description:

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Procollagen Types I (PINP) and III (PIIINP)
Hide Description This is a serum marker of collagen turnover (fibrosis/scar formation).
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum samples were obtained and frozen but never analyzed to obtain procollagen values due to PI departure from study center prior to any batches being sent for analysis
Arm/Group Title POMx Control- Sugar Pill
Hide Arm/Group Description:

The POMx subjects will receive 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Asymmetric Dimethylarginine (ADMA)
Hide Description ADMA is a serum enzyme involved in metabolism of endothelium derived nitric oxide (NO). NO's has an important role in maintaining endothelial homeostasis. Elevated ADMA levels suggest impaired endothelial function.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Serum samples were obtained and frozen but never analyzed to obtain ADMA values due to PI departure from study center prior to any batches being sent for analysis
Arm/Group Title POMx Control- Sugar Pill
Hide Arm/Group Description:

The POMx subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks. Sugar Pill: Matching sugar pill
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title POMx Control- Sugar Pill
Hide Arm/Group Description

15 subjects received 1000 mg of oral POMx for 12 weeks.

POMx, pomegranate polyphenol extract: 1000 mg orally once daily.

The control subjects received a matching sugar pill for 12 weeks.

Sugar Pill: Matching sugar pill

All-Cause Mortality
POMx Control- Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
POMx Control- Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
POMx Control- Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jennifer Cowger
Organization: University of Michigan
Phone: 7345464911
Responsible Party: Jennifer Cowger , MD, MS, University of Michigan
ClinicalTrials.gov Identifier: NCT01102140     History of Changes
Other Study ID Numbers: IMPROVEHF
First Submitted: April 12, 2010
First Posted: April 13, 2010
Results First Submitted: May 18, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017